Pharmacists lose in final ESRD rule

June 16, 2008

A final rule from CMS makes no requirements for a pharmacist to be part of the dialysis team, creating concern among hospital pharmacists.

The Centers for Medicare & Medicaid Services has squelched hopes that pharmacists would be included in dialysis patient care teams. Final rules for the conditions of participation for end-stage renal disease facilities allow dialysis centers to use pharmacists, but CMS will neither require nor pay for pharmacist services in ESRD.

"The final rule puts pharmacy out the back door," said Alan Mutnick, director of clinical effectiveness, Mercy Health Partners, Cincinnati, Ohio. "It doesn't make sense, it is short sighted, and it can have less than ideal outcomes on patients due to the ongoing complications associated with medications."

Studies at Veterans Affairs have found that most dialysis patients are on multiple medications for multiple conditions, including cardiovascular disease, diabetes, and Parkinson's. Nephrologists, dialysis nurses, and other nonpharmacists are less likely to focus attention on these complex comorbidities and their impact on drug-drug interactions, drug-disease states, and the like. That is why the VA requires a pharmacist on dialysis patient care teams, Mutnick said. He added that nonpharmacists may also lack the training to monitor many dialysis-related medications such as erythropoiesis-stimulating agents. "All the erythropoietin in the world does no good for anemia if we don't monitor the patient and give appropriate iron supplementation," he pointed out.

"Pharmacists are the only healthcare professionals trained to catch these problems," she said. "We also provide valuable input into policies and procedures and we are already trained to navigate Part D. Dialysis providers and CMS are looking at the upfront costs. They are ignoring the overall costs of care and patient outcomes."

CMS has been considering the final rule since soliciting public comment on a proposed rule in early 2005. Under the old rules, CMS certified dialysis centers using process-oriented measures. The new rule focuses on patient outcomes, quality assessment, performance improvement, and cost.

While more than 40 pharmacists, pharmacy organizations, and other health professionals supported the role of R.Ph.s on the patient care team, several commenters objected. According to CMS commentary in the final rule, pharmacists focused on quality of care and objectors focused on dollars. "The main concern from dialysis providers stemmed from the potential cost of adding another professional to the care team," St. Peter said. "It was disappointing to pharmacists who work in nephrology."

One commenter noted that at an average annual salary of $73,000, pharmacist services would be cost-prohibitive for the 1,200 dialysis facilities in his organization. Another commenter noted that since Medicare does not cover the cost of pharmaceuticals and treatment, adding a pharmacist to the care team would be fiscally unrealistic. Several commenters noted that pharmacist participation is desirable, but would not be practical in the absence of Medicare funding.

"The end result is that CMS focused on the dollars involved, not on patient care and outcomes," Mutnick said. "We are increasing the vulnerability of dialysis patients with this rule, not improving outcomes."

The final rule, published in the Federal Register on April 15, takes effect on Oct. 14. Mutnick suggested a letter-writing campaign targeting Congress and CMS. A strong showing of support from other healthcare professionals could be more effective at changing minds than more comments from pharmacists, he added. St. Peter suggested additional studies to pinpoint improvements in patient outcomes associated with pharmacist participation. "The pieces are all there," she said, "but we need to draw in the lines to connect them to pharmacists."